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Warnings for Antipsychotic Drugs Not Heeded

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Despite warnings that atypical antipsychotic drugs increased death risk when used to treat elderly dementia patients, a Canadian study found that their use may be increasing among older patients. It is estimated that nearly 30 percent of all nursing home patients have received antipsychotic drugs at one time or another. Atypical antipsychotics include drugs like Risperdal, Seroquel, and Zyprexa.

In the U.S., both conventional – older medications like Haldol and Thorazine – and atypical antipsychotic drugs were approved to treat the symptoms of schizophrenia. They are not approved for use in the treatment of dementia-related symptoms, which can include forgetfulness, poor memory, and an inability to recognize familiar objects, sounds, or people. However, physicians are free to use approved drugs in any way they see fit – a practice known as off-label use.

Warnings that eldery dementia patients treated  atypical antipsychotics have a higher death rate have have not affected how often they are prescribed to older people, researchers from the University of Toronto say. Their analysis of prescription drug data in the province of Ontario found that antipsychotic drug use among the elderly increased 20 percent from the month prior to the first warning in September 2002 to February 2007. About 70 percent of the seniors receiving antipsychotic drugs lived in nursing homes, and about 40 percent of them were 85 or older.

In an article published in the Canadian Medical Association Journal, Dr. Geoffrey Anderson and coauthors on the study wrote that they “found that the 3 warnings about serious adverse events associated with use of atypical antipsychotic agents in elderly people with dementia had a limited effect on the prescription rates of these agents. We also found that the overall rates of use of these drugs actually increased between the first warning in 2002 and the end of our follow-up in 2007.”

“This finding highlights the limited impact of warnings and suggests that more effective approaches are needed to protect vulnerable populations from potentially hazardous medications,” they wrote.

In June, the U.S. Food & Drug Administration (FDA) asked the makers of conventional antipsychotics to add a black box to their labels warning that the drugs they are associated with an increased risk of death when used in elderly patients to treat dementia-related psychosis. In 2005, the FDA announced similar labeling changes for atypical antipsychotic drugs.

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